Method and apparatus for rehydration of lyophilized biologic materials

Abstract

The present invention is a method and an apparatus for packaging lyophilized implants and other medical devices. In accordance with the invention, a lyophilized implant may be packaged for delivery to the surgical site in a sealed, flexible/expandable, sterile inner pouch. The inner pouch may be further packaged within an outer, sterile package. The inner pouch contains a resealable port through which rehydration liquid may be introduced into the inner pouch without opening the inner pouch. The inner pouch may be made of a flexible, substantially non-stretchable material so that the pouch can expand only to a predetermined maximum size to accept a predetermined volume of rehydration liquid. After rehydration, any excess rehydration liquid within the pouch may be removed via the same port. Next, the pouch is opened via a second opening to expose the implant for removal from the package.

The invention claimed is: 
     
       1. An apparatus for hydrating a lyophilized medical implement comprising:
 a lyophilized medical implement, the lyophilized medical implement intended to be properly hydrated with a certain volume of rehydration liquid; 
 a sealed container constructed of a flexible and substantially non-stretchable material, the sealed container comprising an expandable structure having a first state and a second state; and 
 a resealable port on the sealed container for receiving rehydration liquid therethrough into the sealed container; wherein: 
 in the first state, the sealed container has a first internal volume; 
 in the second state, the sealed container has a second internal volume that is a maximum internal volume of the sealed container, the sealed container being configured to have the maximum internal volume being predetermined to correspond to a combined volume of the lyophilized medical implement and the certain volume of rehydration liquid; and 
 the lyophilized medical implement is contained within the sealed container; 
 whereby, the sealed container facilitates proper hydration of the lyophilized medical implement by providing predetermined maximum internal volume that structural limits receipt of rehydration liquid to no more than the certain volume of rehydration liquid for properly hydrating the lyophilized medical implement. 
 
     
     
       2. The apparatus of  claim 1  further comprising:
 a breakable seal on the sealed container through which the lyophilized medical implement may be removed by the sealed container. 
 
     
     
       3. The apparatus of  claim 1  wherein the resealable port comprises a needleless port. 
     
     
       4. The apparatus of  claim 1  wherein the resealable port comprises a port that may be punctured at a point by a puncturing implement and that will reseal around the puncture point upon removal of the puncturing implement. 
     
     
       5. The apparatus of  claim 2  wherein the sealed container comprises first and second container components sealed to each other via a first separable seal and wherein the breakable seal comprises the first separable seal. 
     
     
       6. The apparatus of  claim 1  further comprising an outer package within which the sealed container is enclosed. 
     
     
       7. The apparatus of  claim 6  wherein the outer package comprises first and second outer package components sealed to each other via a second separable seal and wherein the outer container may be opened via the second separable seal. 
     
     
       8. The apparatus of  claim 1  wherein the lyophilized medical implement is one of a biologic tissue material or mesh material prosthesis. 
     
     
       9. The apparatus of  claim 8  wherein the mesh material prosthesis is substantially flat. 
     
     
       10. The apparatus of  claim 9  wherein the expandable structure of the sealed container comprises gussets that are expandable from a first compressed state in which the sealed container has the first internal volume to a second expanded state in which the sealed container has the second internal volume. 
     
     
       11. The apparatus of  claim 1  wherein, in the first state, the sealed container may be shaped to conform substantially to a shape of the lyophilized medical implement contained therein. 
     
     
       12. The apparatus of  claim 1  further comprising an additive container bearing an amount of an additive substance for incorporation into the rehydration liquid, the amount being determined as a function of the quantity of rehydration liquid that can fit within the second internal volume. 
     
     
       13. An apparatus for hydrating a particular lyophilized medical implement with a predetermined volume of rehydration liquid, the apparatus comprising:
 a sealed container constructed of a flexible and substantially non-stretchable material, the sealed container comprising gussets expandable from a first compressed state in which the sealed container has a first internal volume, to a second expanded state in which the sealed container has a second internal volume, the sealed container being constructed so that the second internal volume is predetermined to correspond to a combined volume of (a) the particular lyophilized medical implement and (b) the predetermined volume of rehydration liquid, the second internal volume being a maximum internal volume of the sealed container; 
 the particular lyophilized medical implement contained within the sealed container; and 
 a resealable port on the container for receiving rehydration liquid therethrough into the sealed container. 
 
     
     
       14. The apparatus of  claim 13 , wherein the sealed container is substantially flat when the gussets are in the first compressed state. 
     
     
       15. The apparatus of  claim 13 , wherein the sealed container conforms substantially to a shape of the lyophilized medical implement contained therein when the gussets are in the first compressed state. 
     
     
       16. The apparatus of  claim 13 , wherein the sealed container conforms substantially to a shape of the medical implement contained therein when the gussets are not in the second expanded state. 
     
     
       17. The apparatus of  claim 13 , further comprising an additive container containing an amount of an additive substance for incorporation into the rehydration liquid, the amount being provided as a function of a quantity of rehydration liquid that can fit within the second predetermined internal volume. 
     
     
       18. An apparatus for hydrating a lyophilized medical implement comprising:
 a sealed container constructed of first and second components constructed of a flexible and substantially non-stretchable material, the first component being a tray configured for receiving a medical implement, the second component being a sheet joined to the first component by a seal, the seal being breakable to permit removal of the medical implement; 
 a particular lyophilized medical implement contained within the sealed container; and 
 a resealable port, disposed on one of the first and second components of the sealed container, for receiving rehydration liquid therethrough into the sealed container; 
 the tray comprising a plurality of gussets, the gussets having a first state in which the sealed container has a minimum internal volume, and a second state in which the sealed container has a maximum internal volume, the maximum internal volume being fixed and predetermined to correspond to a combined volume of the particular lyophilized medical implement and a maximum volume of rehydration liquid selected to avoid overhydration of the particular lyophilized medical implement. 
 
     
     
       19. The apparatus of  claim 18  further comprising an outer package enclosing entirely the sealed container, the outer package comprising a first outer package component and a second outer package component sealed to the first outer package component via a second seal, the second seal permitting manual separation of the second outer package component from the first outer package component to permit removal of the sealed container from the outer package. 
     
     
       20. The apparatus of  claim 19 , wherein at least one of said first and second outer package components comprises a chevron-shaped pull tab, and wherein said second seal permits the second outer package component to be peeled away from the first outer package component using hand strength.